510(k) K944827

OREX SURGEON'S GOWN by Thantex Specialties, Inc. — Product Code FYA

K944827 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "OREX SURGEON'S GOWN". The FDA issued a decision of Substantially Equivalent on February 28, 1995. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.